Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) MedDRA version: 21.0 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 100000004864
Conditions
Sponsors
Rhizen Pharmaceuticals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all inclusion criteria to be eligible for participation in this study: 1. Patients must be currently receiving treatment with Tenalisib either as monotherapy or in combination with another agent on a previously approved protocol for hematological malignancies including but not limited to indications DLBCL, iNHL, PTCL, CTCL, CLL and HL. 2. Patients must have had at least one efficacy evaluation following the initiation of Tenalisib in previous study and should have achieved either SD, PR or CR. 3. Patients must have completed at least 6 cycles of Tenalisib in previous study 4. Ability to swallow and retain oral medication. 5. Female patients of child-bearing potential must consent to use two medically acceptable methods of contraception throughout the study period and for 4 weeks after the last dose of Tenalisib. A barrier method of contraception must be included. 6. Male patients must be willing to use adequate contraceptive measures throughout the study period and for 12 weeks after the last dose of Tenalisib. 7. Willingness and ability to comply with trial and follow-up procedures. 8. Willingness to provide new written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: Patients must meet none of the following exclusion criteria to be eligible for participation in this study: 1. Patient has been discontinued from their previous Tenalisib study 4 weeks prior to entering the compassionate use trial. 2. Patient progressed while receiving Tenalisib therapy in his/her previous study. 3. Pregnant or lactating woman. 4. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol. 5. Concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of Tenalisib as single agent or in combination until the withdrawal of subject from the study due to disease progression, unacceptable toxicity or any other reason including consent withdrawal or investigator’s decision. ;Secondary Objective: Time to disease progression;Primary end point(s): Adverse Events (AEs), Grade 3/ 4 AEs and Serious Adverse Event (SAEs). Date of disease progression.;Timepoint(s) of evaluation of this end point: End of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Bulgaria, Georgia, Poland, United States
Contacts
Public ContactAjit Nair / SVP & Head Clinical R&D
Rhizen Pharmaceuticals SA
Outcome results
None listed